Weight Management for Adolescents With IDD (IDDAdol)

University of Kansas

Status: Completed

Conditions: Weight Loss; Down Syndrome; Developmental Disabilities; Body Weight; Intellectual Disability; Body Weight Changes

Treatments: Dietary Supplement: Enhanced Stop Light Diet (eSLD); Behavioral: Face-to-face (FTF); Behavioral: Technology (TECH); Other: iPad with FaceTime; Dietary Supplement: Conventional Diet (CD)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02561754

5R01HD079642 (U.S. NIH Grant/Contract)

STUDY00001857

Details and patient eligibility

About

The goal of this study is to explore the impact of two different diets (conventional vs. enhanced stop light) and two different delivery systems (face-to-face vs. remote) on weight across 18 months in overweight and obese adolescents with intellectual and developmental disabilities.

Full description

Rates of obesity and obesity related chronic health conditions are higher in adolescents with Intellectual and Developmental Disabilities (IDD) than those in the general population. Many of the negative health consequences observed in obese adults are already present in obese adolescents with IDD.

This study is a 3 group randomized trial to evaluate the intervention delivery system and type of reduced energy diet. The investigators will randomize 123 overweight/obese adolescents with mild to moderate IDD to one of 3 groups for an 18 month trial (6 month weight loss; 12 month weight maintenance):

group 1) Face-To-Face/CD

group 2) Technology delivery/CD

group 3) Technology delivery/eSLD.

All participants will receive a progressive program of physical activity. Participants on the CD diet will be asked to consume a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet. Participants on the eSLD will consume pre-packaged portion controlled meals with the addition of 5 fruits and vegetables per day.

FTF will meet with a health educator and will track progress using pen and paper records for both physical activity and diet. TECH groups will receive the intervention using an iPad with the FaceTimeTM application for video meetings with a health educator and will track progress using the Lose it! application for both physical activity and diet.

Enrollment: 110 patients

Sex: All

Ages: 13 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 13-21 yrs
• Mild (IQ of 74-50) or moderate (IQ 40-49) IDD,
• Of sufficient functional ability to understand directions, communicate preferences (e.g. foods), wants (e.g. more to eat/drink), and needs (e.g. assistance with food preparation) through spoken language.
• Overweight or obese (BMI ≥ 85th%ile on CDC growth charts, or waist circumference to height ratio > 0.5
• Living at home with a parent or guardian.
• Internet access in the home.
• No plans to relocate outside the study area over the next 18 mos
• Physician consent for PA and diet.

Exclusion criteria

• Insulin dependent diabetes
• Participation in a weight management program involving diet and PA in the past 6 mos
• Eating disorders, serious food allergies, consuming special diets, aversion to common foods,
• Diagnosis of Prader-Willi Syndrome
• Currently pregnant, planning on/becoming pregnant during the study.
• Unable to participate in moderate to vigorous PA.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 3 patient groups

Face-To-Face/CD

Active Comparator group

Description:

Delivery: Face-to-face Diet: Conventional diet

Treatment:

Behavioral: Face-to-face (FTF)

Dietary Supplement: Conventional Diet (CD)

Technology delivery/CD

Experimental group

Description:

Delivery: Technology Diet: Conventional diet

Treatment:

Behavioral: Technology (TECH)

Other: iPad with FaceTime

Dietary Supplement: Conventional Diet (CD)

Technology delivery/eSLD

Experimental group

Description:

Delivery: Technology Diet: enhanced Stop Light Diet

Treatment:

Dietary Supplement: Enhanced Stop Light Diet (eSLD)

Behavioral: Technology (TECH)

Other: iPad with FaceTime